Applied BioCode, Inc.
Santa Fe Springs, CA, US
Applied BioCode, Inc. appears in FDA device records in Santa Fe Springs, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Applied BioCode, Inc. between 2018 and 2026. The busiest year on record is 2019, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254139 | BioCode® Respiratory Pathogen Panel (RPP) | OCC | Substantially Equivalent | |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent | |
| K192485 | BioCode Respiratory Pathogen Panel (RPP) | OCC | Substantially Equivalent | |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent | |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | PCH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007799234 | 3007799234 | Applied BioCode, Inc. | 12130 Mora Drive Unit #2, Santa Fe Springs, CA 90670 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OZZBordetella Pertussis Dna Assay System
- OZYChlamydophila Pneumoniae Dna Assay System
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- OEMHuman Metapneumovirus (Hmpv) Rna Assay System
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- OEPInfluenza A Virus Subtype Differentiation Nucleic Acid Assay
- NSUInstrumentation For Clinical Multiplex Test Systems
- OLDInternal Polymerase Chain Reaction Control, Not Assay Specific
- OZXMycoplasma Pneumoniae Dna Assay System
- OTGNon-Sars Coronavirus Multiplex Nucleic Acid Assay
- OOUParainfluenza Multiplex Nucleic Acid Assay
- MVUReagents, Specific, Analyte
- OOIReal Time Nucleic Acid Amplification System
- OCCRespiratory Virus Panel Nucleic Acid Assay System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain